Healthy AgingBISCOTENCT05701371
BACTERIA ISOLATION FROM STOOLS COLLECTED FROM CENTENARIANS PEOPLE
An observational study of Healthy Aging, run by Bioaster at 1 site in France.
Trial summary
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. Read more about this study
- Who is it for?
- Ages 95 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Biological samples collection
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2023to 18 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 95 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Elderly (>95 years old) and centenarians people
Who may be able to join
- 95 years and older
- BMI between 18.5 and 25 kg/m2
- Clinical exam normal
- Subject agreeing to participate in the study and not objecting to participate in the study.
- Able and willing to provide samples of blood and faeces
Who cannot join
- Diagnosed acute or chronic gastrointestinal disease or complication (e.g., celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome)
- Infectious gastrointestinal event within 3 months prior to inclusion
- Diabetes
- Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart or liver or biliary disorders, arthritis) or severe chronic disease deemed incompatible with the conduct of the study by the investigator
- Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months prior to inclusion
- Recent food allergy < 3 months prior to inclusion
Show all 20Show fewer
- Antibiotic, antiviral, antifungal, proton pump inhibitor or any other treatment likely to disrupt the microbiota in the 3 months prior to inclusion
- Previous or current use of a treatment that may disrupt the microbiota (e.g. laxatives, antidiarrheals, antacids...) in the last 3 months
- Significant change in dietary habits or physical activities in the 3 months prior to inclusion
- Consumption of more than 2 standard glasses of alcoholic beverages per day
- Smoking > 20 cigarettes per day, illicit drug use,
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Severe psychiatric or neurological pathology
- Completely dependent subject (GIR Score = 1)
- Subject with liquid stools (Bristol Score = 7) or very hard stools (Bristol Score = 1)
- Vaccination in the last month before inclusion
- Subject unable to understand the purpose of the research, answer questions and give their decision to participate in the study
- Subject already included in another research study involving the human subject
- Subject under guardianship and whose guardianship objects to the participation of his/her protectee,
- Subject not affiliated with a social security plan or not a beneficiary of such a plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NON-INTERVENTIONAL STUDY, MULTICENTRIC STUDY, AIMING AT CONSTITUTING A BIOLOGICAL SAMPLES COLLECTION FROM CENTENARIAN PEOPLE
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest. However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species. In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.
The review of the literature shows that certain species present among centenarians have an interest in maintaining the longevity of these individuals. Numerous studies have shown that the intestinal microbiota of centenarians presents a greater diversity compared to groups of younger subjects as well as an enrichment in certain bacteria such as Akkermansia and Christensenella.
Read more
The goal of this observational study is to constitute a biological samples collection from centenarian people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.
Elderly and centenarian people will be recruited in nursing home among the Gerontopole of "Ile de France" network.
Blood (serum + TruCulture tubes) and stools will be collected from each subject.
- Conditions
- Healthy Aging
- Being tested
- Biological samples collection
- Keywords
- Biobank, Observational Study, Blood, Feces, Probiotics, Strain Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collectionOther
blood drawing + feces collection in a dedicated device
| Study group | Role | What they receive |
|---|---|---|
| Centenarian cohort | Not described Receives: Other: Biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a bank of blood and faeces biological samples from centenarians people for research purposes
Study will collect up to 18 mL of blood and minimum of 20g of faeces at one visit from people aged > 95 years.
Measured: One day
Secondary outcomes (3)
Bacteria collection
Isolation and culture of bacteria of interest
Measured: One day
Fecal microbiota composition
Measures of alpha and beta diversity of fecal samples
Measured: One day
Immuno-modulatory properties of isolated strains
Cellular assays with immune related readout to decipher pro and/or anti inflammatory properties
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start6 Jun 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril GUYARD, Study director, BioasterOlivier HANON, Principal investigator, Gérond'if
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701371
- Sponsor's protocol ID
- 2022-A02293-40
- Acronym
- BISCOTE
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-INTERVENTIONAL STUDY, MULTICENTRIC STUDY, AIMING AT CONSTITUTING A BIOLOGICAL SAMPLES COLLECTION FROM CENTENARIAN PEOPLE
- ClinicalTrials.gov ID
- NCT05701371
- Acronym / sponsor ID
- BISCOTE / 2022-A02293-40
- Conditions
- Healthy Aging
- Keywords
- Biobank, Observational Study, Blood, Feces, Probiotics, Strain Isolation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioasterUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest. However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species. In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.
The review of the literature shows that certain species present among centenarians have an interest in maintaining the longevity of these individuals. Numerous studies have shown that the intestinal microbiota of centenarians presents a greater diversity compared to groups of younger subjects as well as an enrichment in certain bacteria such as Akkermansia and Christensenella.
The goal of this observational study is to constitute a biological samples collection from centenarian people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.
Elderly and centenarian people will be recruited in nursing home among the Gerontopole of "Ile de France" network.
Blood (serum + TruCulture tubes) and stools will be collected from each subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Centenarian cohort | – | Other: Biological samples collection |
Who may qualify
- Ages
- 95 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly (>95 years old) and centenarians people
Key inclusion criteria (5 listed)
- 95 years and older
- BMI between 18.5 and 25 kg/m2
- Clinical exam normal
- Subject agreeing to participate in the study and not objecting to participate in the study.
- Able and willing to provide samples of blood and faeces
Key exclusion criteria (20 listed)
- Diagnosed acute or chronic gastrointestinal disease or complication (e.g., celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome)
- Infectious gastrointestinal event within 3 months prior to inclusion
- Diabetes
- Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart or liver or biliary disorders, arthritis) or severe chronic disease deemed incompatible with the conduct of the study by the investigator
- Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples collectionblood drawing + feces collection in a dedicated device | Other | Centenarian cohort |
Primary outcome
Establishment of a bank of blood and faeces biological samples from centenarians people for research purposes
Time frame: One day
Study will collect up to 18 mL of blood and minimum of 20g of faeces at one visit from people aged > 95 years.
3 secondary outcomes
Bacteria collection
Time frame: One day
Fecal microbiota composition
Time frame: One day
Immuno-modulatory properties of isolated strains
Time frame: One day
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril GUYARD study director
Bioaster
Olivier HANON principal investigator
Gérond'if
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by Bioaster at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a bank of blood and faeces biological samples from centenarians people for research purposes (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.